Genesis G21108Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D768G211080), received between Apr 19, 2021 and Apr 19, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K101545); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2021Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 11684558 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101545. One submission often covers many models, so check the product and lot details in each record.

• Z-1485-2018 · Mar 13, 2018 · Terminated
  Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
• Z-0923-2013 · Jul 5, 2011 · Terminated
  Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully
• Z-0924-2013 · Jul 5, 2011 · Terminated
  Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or ful